A federal judge has issued a preliminary injunction halting the Department of Health and Human Services’ (HHS) 340B Rebate Model Pilot Program, which was scheduled to take effect on January 1, 2026. The December 29, 2025 ruling temporarily prevents implementation of the rebate program that would have fundamentally changed how safety-net hospitals and clinics purchase discounted drugs under the 340B Drug Pricing Program.
On April 23, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a new COVID-19 toolkit. While the toolkit is directed to the states, it should serve the American telehealth community as a focal point for the organization and alignment of the infinite number of state and federal regulations relevant to telehealth. So, it serves as a great organizing tool for provider’s own operational use but also as an architecture for providers to catalogue the changes they would like to suggest to the states in order to improve access to telehealth.
The Federal Communications Commission (“FCC”) has opened the COVID-19 Telehealth Program Application portal and is now accepting applications for the COVID-19 Telehealth Program (the “Telehealth Program”). Authorized by the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), the Telehealth Program will provide $200 million in funding to assist eligible health care providers deliver telehealth services to patients in their homes or other mobile locations in an effort to combat the novel Coronavirus 2019 disease (“COVID-19”). The funding is available for eligible health care providers responding to the COVID-19 pandemic by fully compensating providers for their telecommunication services, information services, and devices necessary for them to provide critical telehealth services. Notably, the Telehealth Program is not currently available to certain types of health care providers, including for-profit providers. Consequently, some providers, including local hospitals that are part of a larger for-profit health system, may find themselves ineligible for telehealth funding.
In a March 24th letter to all of the nation’s Governors, Secretary Alex Azar of the Department of Health and Human Services (“HHS”) called upon states to take immediate action to loosen regulations that present obstacles to the delivery of effective in person and telehealth services during the COVID-19 emergency. In an effort to “carry out a whole-America response to the COVID-19 pandemic,” Secretary Azar asked governors to urgently take steps to “extend the capacity of the health care workforce.”
As the novel coronavirus outbreak continues, the federal government and commercial health insurers have taken significant steps to increase Americans’ access to treatment and testing. In the past week, the federal government and private insurers have issued a number of guidance documents expanding coverage and payment requirements in an effort to minimize the spread of the virus. As with any changes in coverage and reimbursement, healthcare providers offering telehealth services should carefully review these changes and take steps to ensure that all regulatory and coverage requirements are met prior to submitting claims for reimbursement.
On March 6, 2020, the bipartisan Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 (“Coronavirus Appropriations Act”) was signed into law authorizing federal spending to combat the ongoing coronavirus outbreak in the United States. This Act, among other things, gives the United States Department of Health and Human Services’ (“HHS”) secretary the authority to temporarily waive certain Medicare requirements for telehealth services.
The Centers for Medicare and Medicaid Services (“CMS”) currently reimburses a limited set of telehealth services provided to Medicare beneficiaries subject to certain criteria under section 1834(m) of the Social Security Act. Generally, the patient receiving telehealth services must be located at one of eight “originating sites”, which include hospitals, physicians’ offices, and rural health clinics. In addition, the originating site must meet certain geographic requirements which have essentially limited the availability of telehealth to patients in rural areas. These requirements have long posed a hurdle to the expansion of telehealth despite the industry’s demand for lessened restrictions. However, with the rapid spread of the coronavirus and the possibility of facing large scale isolations and quarantines, lawmakers have signaled their willingness to expand access to telehealth to fight against this public health crisis.
Within the Coronavirus Appropriations Act is the Telehealth Services During Certain Emergency Periods Act of 2020, which sets forth the waiver authority for the secretary of HHS regarding the certain telehealth requirements. Under the Telehealth Services During Emergency Periods Act, the secretary is authorized to temporarily waive the originating site and geographic requirements for telehealth services provided to Medicare beneficiaries located in an identified “emergency area” during an “emergency period” when provided by a qualified provider. To qualify for the waiver, the provider must have treated the patient within the previous three years or be in the same practice (i.e., as determined by tax identification number) of a practitioner who has treated the patient in the past three years. The bill also lessens the telecommunications requirements by allowing Medicare beneficiaries to receive telehealth services via their smartphones (i.e., telephones that allow for real time, audio-video interaction between the provider and the beneficiary). Because the federal government has declared a nationwide public health emergency as a result of the coronavirus, the waiver will apply across the country until there is no longer a nationwide public health emergency.
On June 1, 2019, the United States Pharmacopeia (“USP”) published the final revisions to its pharmaceutical sterile compounding standards (“chapter <797>”). Chapter <797> sets forth standards for the preparation of compounded sterile medications to help ensure products are safe and effective and reduce risks such as contamination or incorrect dosing. The most recent revisions implement new standards and revise existing ones based on recent scientific and technological developments. The chapter <797> revisions also incorporate stakeholder input raised during the July 2018 to November 2018 public comment period, much of which concerned allergens, beyond-use dating, and the general ambiguity throughout the chapter.
The USP’s most recent revisions to chapter <797> are extensive and those who prepare compounded sterile products (“CSPs”) are advised to familiarize themselves with the new standards. Significant changes include:
On Tuesday, June 18, 2019, our team of legal professionals and industry experts hosted a Compliance Considerations for Pharmacy Sale or Acquisition Webinar that took a look at the regulatory pitfalls and problems that can arise in a pharmacy transaction.
The free on-demand recording will provide real-life examples of what to do – and not
This year’s National Home Infusion Association (NHIA) conference kicked off with the 2nd Annual Sterile Compounding Forum. The well-attended track provided an overview of the state of sterile compounding, insight into the most common citations confronting sterile compounders, considerations for compliance and risks relating to compounding, background on how states and the FDA are implementing rules and regulations, including those involved in the delivery of home infusion products.
We are pleased to sponsor the NHIA conference and participate in the following activities:
If you happen to miss our NHIA Talk Infusion Webinar on Compliance and Risk Considerations for Compounding Pharmacies, please click on the link to enjoy a free on-demand recording.
Our program guides you through the current landscape and common compliance concerns in compounding. We will help you understand the focus of FDA and state
The regulation of pharmacies at the state level might not be what Justice Louis Brandeis had in mind as an example of a “laboratory of democracy,” but for pharmacists and consumers, state-level policy-making can have important real-world effects and encourage efforts on the federal stage. Over the past twelve months a number of regulatory trends have played out that define the current operating environment for pharmacies, many of which are anticipated to continue in 2019.